Methods for the assessment of risk and treatments for liver cancers and lethal liver disease complications
AssigneesBoard of Regents, The University of Texas System, Universite De Strasbourg, Institut National De La Sante Et De La Recherche Medicale (Inserm), HôPitaux Universitaires De Strasbourg (Hus)
InventorsYujin Hoshida, Naoto Fujiwara, Amit G. Singal, Thomas F. Baumert
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Abstract
Disclosures herein are directed to methods and compositions for predicting high- and low-risk liver disease in patients. Based on the results achieved from the methods and compositions disclosed herein, liver disease patients can be classified into a prognostic risk group, which enables early diagnosis and prevention of HCC and other lethal complications. Methods and compositions disclosed herein substantially improve the poor prognosis of subjects having or at risk for one or more liver diseases.
Claims22
A method of predicting risk for developing hepatocellular carcinoma (HCC) in a subject comprising determining a prognostic liver secretome signature (PLSec) score for the subject, wherein the subject is having or is suspected of having a disease, a condition, or a combination thereof that predisposes the subject to HCC, wherein the method further comprises a method of obtaining the PLSec score for the subject, wherein the method of obtaining the PLSec score comprises:
- (a) obtaining a sample of blood from the subject;
- (b) subjecting the sample to a multi-analyte profiling assay for protein quantification of vascular cell adhesion molecule 1 (VCAM-1), insulin-like growth factor-binding protein 7 (IGFBP-7), gp130, matrilysin, interleukin-6 (IL-6), C—C motif chemokine ligand 21 (CCL-21), angiogenin, and protein S;
- (c) normalizing protein quantification measurements of VCAM-1, IGFBP-7, gp130, matrilysin, IL-6, CCL-21, angiogenin, and protein S to median fluorescent intensity;
- and,
- (d) converting the normalized protein quantification measurements of VCAM-1, IGFBP-7, gp130, matrilysin, IL-6, CCL-21, angiogenin, and protein S into an aggregated score, wherein the aggregated score is the PLSec score.
2-14. (canceled)
A diagnostic kit for determining a prognostic liver secretome signature (PLSec) score of a subject comprising one or more reagents for use in a multi-analyte profiling assay, wherein the one or more reagents for use in a multi-analyte profiling assay comprises beads labeled with antibodies to vascular cell adhesion molecule 1 (VCAM-1), insulin-like growth factor-binding protein 7 (IGFBP-7), gp130, matrilysin, interleukin-6 (IL-6), C—C motif chemokine ligand 21 (CCL-21), angiogenin, and protein S.
-21. (canceled)
A method of predicting risk for developing one or more symptoms of hepatic decompensation in a subject comprising determining a prognostic liver secretome signature (PLSec) score for the subject, wherein the PLSec score is determined by a method comprising:
- (a) obtaining a sample of blood from the subject;
- (b) subjecting the sample to a multi-analyte profiling assay for protein quantification of vascular cell adhesion molecule 1 (VCAM-1), insulin-like growth factor-binding protein 7 (IGFBP-7), gp130, matrilysin, interleukin-6 (IL-6), C—C motif chemokine ligand 21 (CCL-21), angiogenin, and protein S;
- (c) normalizing protein quantification measurements of VCAM-1, IGFBP-7, gp130, matrilysin, IL-6, CCL-21, angiogenin, and protein S to median fluorescent intensity;
- and,
- (d) converting the normalized protein quantification measurements of VCAM-1, IGFBP-7, gp130, matrilysin, IL-6, CCL-21, angiogenin, and protein S into an aggregated score,
- wherein the aggregated score is the PLSec score,
- wherein the subject is having or is suspected of having a disease, a condition, or a combination thereof that predisposes the subject to hepatic decompensation.
The method of 36, wherein the risk-based screening comprises ultrasound, MRI, CT, measuring circulating cell-free methylated DNA, AFP, or any combination thereof.
Dependencies are inferred from the claim text.